RFA-AI-98-001: HUMAN IMMUNOLOGY CENTERS OF EXCELLENCE

Department of Health
and Human Services (HHS)

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HUMAN IMMUNOLOGY CENTERS OF EXCELLENCE Release Date: March 6, 1998 RFA: AI-98-001 P.T. National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: August 23, 1998 Application Receipt Date: October 23, 1998 APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN AN NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites applications for program project grants to support interactive, synergistic studies on the basic mechanisms that regulate human immune responses. Of primary interest are multidisciplinary research programs focused on defining clinically relevant genetic, biochemical, cellular and systemic parameters of human immunity and tolerance. Studies should strive to identify basic principles of immune regulation and to facilitate the translation of knowledge from animal studies into clinical approaches for the prevention and treatment of human diseases such as autoimmunity, allergy, infections, transplant rejection and inflammatory diseases. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Human Immunology Centers of Excellence, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic for-profit and non- profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support will be the program project (P01) grant. This type of award supports broadly based multidisciplinary research programs that have a well-defined central research focus or objective. An important feature is that the interrelationships among the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project was pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. The award also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the award. Responsibility for the planning, direction, and execution of the proposed projects will be solely that of the applicant. The total project period may not exceed five years. At this time, the NIAID is administratively limiting the duration of P01 grants to four years; this administrative limitation may change in the future. The earliest anticipated award date is August, 1999. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for this RFA will $3.0 million. In fiscal year 1999, the NIAID plans to make approximately 4 awards related to this RFA. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Applications requesting budgets in excess of $750,000 in total (direct and indirect) first-year costs must obtain approval from the Program contact listed in INQUIRIES prior to submission. The usual PHS policies governing grants administration and management will apply. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present RFA. RESEARCH OBJECTIVES Background Considerable progress in understanding the basic mechanisms of immune regulation has occurred in recent years, but comprehensive analyses of normal and pathogenic immune responses have been conducted primarily in non-human animal model systems. Many aspects of human immunology are still poorly defined and pathways that are important in animal systems might not represent optimal therapeutic targets in man. Infectious and immune-mediated diseases currently impose enormous economic and social costs, and a more complete understanding of the human immune system and the ways in which it can be safely modified will greatly facilitate the development of new clinical applications. Human studies are limited by a more restricted set of experimental protocols than can be performed in animals. Extensive genetic heterogeneity and environmental variations further increase the difficulty of obtaining detailed information about the complex processes that govern immune responses in vivo. However, current experimental approaches allow for the detection and quantitation of an increasing number of immunological parameters that correlate with human disease pathogenesis and outcomes. Advances in molecular biology, for example, have provided mechanistic explanations for diseases of abnormal cell development, such as lymphoproliferative disorders and immunodeficiency diseases. Enhanced techniques for HLA typing and gene sequencing have generated new paradigms for understanding transplant rejection and disease susceptibility, and the ability to produce recombinant cytokines and humanized antibodies provides promising new immunomodulatory agents for therapy. Rapid advances in determining the three- dimensional structures of proteins that regulate the immune system also provide new opportunities for innovative drug development for both infectious and immune- mediated diseases. Furthermore, the extraordinary accomplishments of the human genome project will soon result in an unprecedented wealth of genetic information, thus facilitating advances in defining the biochemical basis for human immune functions, and in identifying novel cellular and molecular targets for vaccine development and immune intervention. Research Objectives and Scope The goal of this RFA is to support highly integrated, multidisciplinary research programs focused on defining the mechanisms responsible for normal or pathogenic human immune responses. Innovative and definitive approaches to the study of human immune regulation are of particular interest. Projects that incorporate clinically relevant animal models into a complementary framework of human studies that are also included in the program are acceptable. In addition, relevant clinical studies in humans are within the scope of this RFA. Research topics of interest include, but are not limited to, the following: o identification of the types of human immune responses, such as dominant CTL, NK, specific cytokine or antibody isotype responses, that are critical for protection from, or reversal of, specific disease states (autoimmunity, allergy, transplant rejection, infectious diseases); o novel, minimally invasive experimental approaches that move beyond PBL assays in order to identify mechanisms of human immune regulation or to monitor antigen- specific immune responses; o identification of the most effective antigen delivery systems for the induction of immunity or tolerance; o characterization of the mechanisms responsible for differential regulation of immune responses in children, adults and the elderly; o definition of ontogeny of the human immune system and identification of essential parameters for reconstitution of deficient or ablated immunity; o identification of molecular targets applicable to the development of novel adjuvants and vaccines for human use; o characterization of molecular mechanisms responsible for human T and B memory cell generation and maintenance; o immunoregulation by cytokines and their receptors; and o genetic control of immune responsiveness and immune effector mechanisms. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigators may obtain copies from these sources or from Dr. Helen Quill (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by August 23, 1998, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Kevin Callahan at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (September 1997); this brochure is available from NIAID staff listed in INQUIRIES and via the WWW at: http://www.niaid.nih.gov/ncn/grants/ multibron.htm Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: asknih@od.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES" and the RFA number "AI-98-001" and the words "Human Immunology Centers of Excellence" must be typed in. Applications must be received by October 23, 1998. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/95) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. It is highly recommended that the appropriate NIAID program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contact under INQUIRIES). Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to Dr. Kevin Callahan at the address listed under INQUIRIES. Concurrent submission of an R01 and a Component Project of a Multi-project Application: NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (September 1997); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. The brochure presents specific instructions for sections of the PHS 398 (rev. 5/95) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions on pages 5-20 of the PHS 398 booklet. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review and for responsiveness by NIAID staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The general criteria for P01 grant applications are presented in the NIAID brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (September 1997). AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the NIAID brochure "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" as well as inquiries regarding programmatic (eligibility and research scope) issues, may be directed to: Helen Quill, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A22 Bethesda, MD 20892-7640 Telephone: (301) 496-7551 FAX: (301) 402-2571 Email: Helen_Quill@nih.gov Direct inquiries regarding preparation of the application and review issues, and address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Kevin Callahan, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C-20 Bethesda, MD 20892-7610 Telephone: (301)496-2550 Email: kc92t@nih.gov Direct inquiries regarding fiscal matters to: Pam Fleming Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C-25 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: pf49e@nih.gov Schedule Letter of Intent Receipt Date: August 23, 1998 Application Receipt Date: October 23, 1998 Scientific Review Date: February 1999 Advisory Council Date: May 1999 Earliest Date of Award: August 1999 AUTHORITY AND REGULATIONS This program is supported under authorization of the Public Health Service Act, Sec. 301 (c), Public Law 78-410, as amended. The Catalogue of Federal Domestic Assistance Citation is No. 93.855 - Immunology, Allergy, and Transplantation Research. Awards will be administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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